Composite bandage particularly suited to non-planar patient contact

ABSTRACT

A hospital type of bandage integrates an absorbent pad and non-stick layer with a fluid-impermeable outer layer and an adhesive in a single composite structure. In a preferred embodiment the invention further includes means which may be used to turn the bandage inside out upon removal, so that surfaces once contacting a patient are no longer externally exposed. A bandage according to the invertible embodiment preferably includes a pocket formed on the side of the bandage facing away from the patient after application, this pocket being large enough to accommodate at least a portion of a human hand, and inside this pocket and located opposite the entrance is a means for grasping which may be pulled outwardly through pocket opening, thereby inverting the entire structure. Various forms of devices for grasping are possible as alternatives, including a string, a tab and a tab with one or more finger-receiving holes. Means are further included for sealing the inverted structure, preferably in the form of a flap and associated adhesive.

REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.09/188,752, filed Nov. 9, 1998, now U.S. Pat. No. 6,225,523 which is a;continuation-in-part of U.S. patent application Ser. No. 08/886,792,filed Jul. 1, 1997 now U.S. Pat. No. 5,833,646, which is acontinuation-in-part of U.S. patent application Ser. No. 08/350,822,filed Dec. 7, 1994, now U.S. Pat. No. 5,643,189.

FIELD OF THE INVENTION

The present invention relates generally to larger bandages of the typeused, for example, in hospital settings and, more particularly, to acomposite bandage with integrated absorbent, adhesive andfluid-impermeable layers. In a preferred embodiment the bandage mayfurther be turned inside-out to self-contain surfaces once exposed tothe patient.

BACKGROUND OF THE INVENTION

The AIDS epidemic, in particular, has caused medical personnel to takeextreme precautions to avoid exposure to blood and other bodily fluidswhich might be infected. Doctors and dentists now wear rubber gloves andface masks in even the most routine situations, and various safetydevices such as protective needles and so forth are being introducedwith increasing frequency.

The removal of bandages and other wound dressings is an area wherefurther safety measures are warranted. There are no composite wounddressings which integrate adhesive and absorbent layers in combinationwith a fluid impermeable cover. Instead, physicians routinely open afirst sterilized pouch containing an absorbent pad and place that on thewound. Then rolls of sterilized tape are opened and, quite often, notonly are the edges of the absorbent pad taped to the patient, butexcessive tape is often used to cover the entire pad outer surface toensure a fluid-tight seal. This is time consuming, and also results inmultiple items requiring independent sterilization and considerablepackaging waste.

The used bandages are discarded by placing them into specially markedbags which, in turn, are placed in specially marked disposal containers.This practice may expose associated personnel to dangerous pathogenssince until such dressings are placed in their specially marked disposalcontainers, the surfaces once applied to the patient are outwardlyunprotected. Also, there exists no consistent technique for placementwithin such bags, which may lead to contact with personnel during theprocess of insertion into the disposal bag or container.

SUMMARY OF THE INVENTION

The present invention solves problems associated with the applicationand disposal of wound dressings by providing a bandage which integratesan absorbent pad having a non-stick layer with a fluid-impermeable outerlayer and adhesive in a single composite structure, so that only oneitem need be sterilized and accounted for. In a preferred embodiment,the invention further includes means which may be used to turn thebandage inside-out upon removal, so that surfaces once contacting apatient are no longer externally exposed. In this way, the bandageitself forms its own disposal pouch, thus solving the above-mentionedproblems, including possible exposure during bandage removal andtransfer, and further obviates the necessity for separate sterilizeddisposal vehicles.

In the invertible embodiment, a bandage according to the inventionpreferably includes a pocket formed on the side of the bandage facingaway from the patient after application, this pocket being large enoughto accommodate at least a portion of a human hand, preferably the entirehand. Inside this pocket and located opposite the entrance to the pocketis a graspable device which may be pulled outwardly through the pocketopening, thereby inverting the entire structure. Various forms ofgrasping means are possible as alternatives, including a string, a taband a tab including one or more finger-receiving holes. Means arefurther included for sealing the bag once it is inverted, preferably inthe form of a flap and associated adhesive. In the preferred embodimentthis flap is also stiffened to be conveniently held by the hand notperforming the actual inversion, with the two hands then cooperating fora smooth motion as the bandage structure is turned inside out. Othersealing means may be provided as alternatives, however, such as adhesivetape, a zip-lock type of fastener, or one or more semi-rigid butflexible cooperating elements disposed proximate to the pocket opening.

The semi-rigid or rigid flap is preferably folded near the mouth of thepocket prior to inversion so as to provide a stiffening proximate to themouth of the pocket to help maintain structural integrity duringinversion. The bandage may also include other, additional means tostiffen the mouth of the pocket opening and may further include someform of holding member extending outwardly from the side of the bandageat a point near to the entrance to the pocket, preferably in the form ofa rigid or semi-rigid bar or stick-like protrusion which may be held byone hand while the bandage is inverted with the other. The protrusionmay further be hingedly affixed to the side of the bandage to form amore compact structure until it is employed, and may fold over and sealthe entrance to the pocket following inversion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an oblique drawing of a bandage formed in accordance withthis invention, with an area being folded over to show its absorbent andadhesive portions;

FIG. 1B is an oblique drawing illustrating a preferred form of packagingfor a bandage constructed according to the invention;

FIG. 2A is an oblique drawing of an invertible version of the bandage,with a portion of the outer layer being removed to expose a pull tab;

FIG. 2B is an oblique drawing of an invertible version of the bandage,with a portion of the outer layer being removed to show a string usedfor inversion;

FIG. 2C is an oblique drawing of the invertible version of the bandageof FIG. 2B in the process of being inverted upon removal;

FIG. 3 is an oblique drawing of the invertible bandage in a final,inverted form;

FIG. 4 illustrates an alternative embodiment of the invention includingmeans for holding and stabilizing the opening of the pocket with onehand while performing the inversion operation with the other;

FIG. 5 is an oblique drawing of an alternative structure wherein thepatient-contacting surface slider into an integral disposal pouch;

FIG. 6A illustrates an alternative embodiment of the present inventionwhich shows gathering along a peripheral edge;

FIG. 6B illustrates a further embodiment of the invention which showsgathering in the form of one or more V-shaped notches on a peripheraledge;

FIG. 7A illustrates an embodiment of the invention wherein a section ofabsorbent material is adhered to an existing bag structure having alarger area;

FIG. 7B is an exploded-view drawing illustrating steps that may be usedto manufacture the embodiment of FIG. 7A in discrete form; and

FIG. 8 illustrates a preferred method of manufacturing invertiblebandages on a continuous web basis.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed toward bandages such as surgicaldressings large enough to be used in post-operative situations, forexample. Thus, bandages according to the invention range in size from acouple inches or so per side up to several inches per side, and arepreferably rectangular in shape, in contrast to the small bandages andadhesive strips used for minor cuts and bruises. FIG. 1A shows at 10 abasic embodiment of a bandage formed according to the inventionincluding an absorbent layer or pad 16 with non-stick layer 17 attachedto a larger, fluid-impermeable layer 18. The layer 18 preferably extendsbeyond the pad 16 around its entire periphery by an amount depicted as“A,” with at least a portion of this outwardly extending region of layer18 including an adhesive at least between the pad and the outer edge ofthe layer 18 for securement to the patient.

In a preferred construction, a single fluid-impermeable layer 18 isprovided with a relatively strong adhesive across the entirety of one ofits two surfaces, which is used to hold the pad 16 to that surface withthe remaining exposed peripheral portions with adhesive being used forpatient contacting. Alternatively, further layers may be provided, suchas a separate adhesive layer and fluid-impermeable layer. Although thefigure shows substantially the same width of “A” around the entireperiphery of the pad 16 and round corners, variations of thesegeometrical considerations are possible, as is non-rectangular overallshapes, such as ovals and circles, and so forth.

Preferably, the absorbent wound-contacting pad 16 includes a non-stickouter surface such as an Adaptic™-type layer (shown with hashedmarkings), which is popular in the profession since fluids may passtherethrough, but with the outer surface not adhering to the patient orwound. Also, in the preferred construction, at least the adhesiveexposed for securement to the patient is preferably of the Microfoamtype, as this is sufficiently strong enough to provide a good bond tothe skin, but which is also flexible and tends to roll off the skin whenlifted and pulled laterally, a feature which is advantageous for theinvertible version of the bandage, as should be evident as discussedbelow. As with the variations possible in geometrical shape, variationsin the use of the absorbent, adhesive and fluid-impermeable materialsare also possible.

FIG. 1B shows a preferred delivery method of the bandage of FIG. 1A,wherein two outer sheets 12 and 14 are used to entirely contain thebandage, and are accordingly the only materials that need to bediscarded upon application. As shown in FIG. 1B, these outer layers 12and 14, which may be of paper, foil, plastic or other alternativematerials, are preferably slightly larger than the bandage itself andare sealed together beyond the extent of the bandage with an adhesiveshown by the stippling, which releases as the two halves 12 and 14 arepulled apart as shown. The surface of the layer 14 facing the exposedadhesive portions of the bandage of layer 18 may further include anon-stick type of surface to ensure that the bandage does not stick tothe packaging layer so as to cause problems upon removal. Dog-ear tabs20 may further optionally be provided as a convenient grasping means forpulling apart the layers 12 and 14 during removal of the bandage 10.

FIGS. 2A-2C show embodiments of the bandage which enable it to be turnedinside out upon removal, thus causing surfaces once contacting a patientto be pulled into an internal cavity formed during the inversionprocess. This capability reduces exposure to harmful pathogens inseveral ways, including the ability to dispose the bandage as soon aspractically possible upon its removal from the patient, and eliminationof the need for separate disposal bags and containers, which might causeaccidents during bandage transfer.

FIG. 2A shows one embodiment of an invertible bandage structure havingan outer layer 30 which forms a pocket on the surface of the bandagefacing away from the patient after application. The pocket has anopening or mouth 32 at its proximal end and, inside the pocket at itsdistal end 34 there is bonded, attached or sewn some form of graspingmeans used for the inversion process. In FIG. 2A, with a portion of theouter layer 30 removed as shown, this grasping means takes the form of atab 36 which may be flexible or rigid and which may or may not includeone or more holes 38 into which a finger may be inserted.

To invert the bandage of FIG. 2A, the individual removing the bandageinserts at least a portion of the hand, preferably the entire hand, intothe opening 32 of the pocket, grabs the tab 36, which is preferablycentrally attached with respect to the distal end 34, and pulls the tab36 out through the mouth 32, thus inverting the structure. In thisparticular embodiment, the overall shape of the bandage may beneficiallybe tapered away from a more rectangular form shown in broken lines 31.Such a tapered structure should assist in helping the inversion processto commence in a smooth manner. Additional tapering, as indicated bybroken lines 37, may likewise optionally be provided. Although thetapering indicated by 37 may actually slightly increase the difficultyin inverting the structure midway through the inversion process, such atapering might result in a final structure which is much more easilysealed into its contained, final form. As mentioned previously,geometrical considerations such as the size, shape and tapering of thebandage, are all options which remain in keeping with this invention,depending upon the size of the bandage, its application, and so forth.

FIG. 2B illustrates in oblique form yet another alternative version ofthe invertible embodiment of the invention, in this case a bandagehaving an outer layer 50 which faces away from the patient when thebandage is applied, and a mouth formed on its proximal end. In contrastto the tab of FIG. 2A, however, the distal end has attached, sewn orotherwise bonded in its corners 58 a wire, cord or string 56. To removethis version of the bandage, a portion of the hand is inserted into themouth 52 and the string 56 is grabbed with one or more fingers. Oneadvantage of this configuration is that by pulling centrally on thestring 56, the corners 58 naturally tend to move toward the centerportion of the bandage proper, thus easing the inversion motion.

FIG. 2C shows, in oblique form, a bandage according to alternative 2B inthe process of being inverted and removed from the patient 120. At itsproximal end 105, the bandage includes an opening or mouth 140 intowhich at least a portion of an individual's hand is inserted. Thisopening 140 preferably including a flap 160 which may later be used toseal the bandage in its final inverted form. The flap preferably foldsto an extent into the opening 140 at 141, thus advantageously creating asemi-rigid or substantially rigid edge along the top of the opening 140.Having the flap 160 initially folded into the mouth 140 prior toinversion assists in the inversion process, as does the rigidityresulting along the top edge of the opening 140.

The underside of the flap 160 as depicted in FIG. 2 preferably furtherincludes an adhesive 143 which may serve various purposes. Prior toinversion, for example, this adhesive 143 may held to hold flap 160 downagainst the top surface of the upper layer forming the pocket. Thisadhesive action should not be too strong, however, since the flap 160will need to release from this upper surface during the final stages ofinversion. As such, a non-stick or reduced-tack surface may be provideddirectly beneath the adhesive 143 on the upper surface forming the toplayer of the pocket to ensure that a release is achieved.

Once the bandage is fully inverted, this adhesive 143 will be used toseal the bag upon closure. In order to ensure a sufficient seal, asecond adhesive region 143′ may be provided corresponding to that of 143in the correct area upon inversion such that the flap may be folded overand pressed thereagainst. For example, adhesive 143 and its accompanyingadhesive area 143′ may both be of the contact adhesive variety. Variousother techniques are possible for the sealing of the bandage however,including a separate piece of tape, a zip-lock type of structure, and soforth, as previously mentioned. The adhesive area 143′ also serves tohold the opening 140 closed until needed, but this adhesive actionshould not be strong enough to confound easy entry into the pocket. Itis when adhesive areas 143 and 143′ are brought together, as per FIG. 3,that bonding of the two surfaces preferably be substantial.

At the distal end of the bandage 106 and internal to the pocket is someform of grasping means, in this case a string 142 attached at points 146within the internal bandage structure, such as that depicted in FIG. 2B.The individual removing the bandage may thus grab the string 142 asshown with one or more fingers and pull in the direction of the pocketopening 140 to perform the inversion process. At the same time, as theone hand 144 of the individual inverting the bandage pulls on the string142, the other hand 148 may conveniently grasp the distal end of theflap 160 with a finger 149 inserted through a hole 150 formed in theflap 160. As the string 142 is pulled, the internal distal ends 146 arepulled inwardly, so that the adhesive portion 152 and absorbent portion154 are curled or otherwise deformed as the bandage is inverted thesesurfaces 152 and 154 being pulled into an inverted pouch created as thehands 144 and 148 are pulled apart from one another. Although the flap160 is shown in generally triangular form with a rounded end otherconfigurations are possible, and the number of holes 150 may beincreased or decreased.

FIG. 3 shows at 200 the bandage of FIG. 2C in its final inverted form.The string 142 will now be externally exposed and, indeed, may be usedfor convenient carrying. The flap 160 may now been folded over so as toseal the entrance through which the bandage was inverted. The brokenlines 152 and 154 are used to indicate a portion of the patientcontacting areas, which are now entirely enclosed within an internalcavity, with a new opening 140′, formed through the inversion process.As seen in FIG. 3, the adhesive 143 on flap 160 may now be folded overso as to make contact with adhesive 143′, thus sealing the invertedstructure.

FIG. 4 illustrates the process of inverting yet a further alternative ofthe bandage, in this case including an optional protrusion in the formof a stick or bar 310 which may have a hinge 311 so that stick 310 maybe used to seal the opening 322 prior to inversion and may additionallybe folded back onto the opening of the inverted bandage to seal it inlieu of a flap or separate tape pieces. As shown, in operation, anindividual removing the bandage 300 will grasp the stick 310 with afirst hand 312 while grabbing the internal grasping means at the distalend of the bandage with his or her second hand 332. The grasping meansin this case is a tab 330 having a hole to receive a finger of hand 332.In FIG. 3, the individual removing the bandage is partially through theprocess of inverting the same, such that the distal end of the bandageis now distorted as the tab 330 is being pulled between edges 320 whichmake up the opening 322. Edges 320 may further include embedded orexternal stiffening members (not visible in FIG. 4) which, inconjunction with the protruding stick 310, may alternatively furtherstabilize the opening 322 of the proximal end of the bandage untilfinally inverted. Stick 310 may be constructed and hinged in such amanner allowing it to be folded back over the open end to seal theinternal cavity formed through the inversion process.

Broadly, in one embodiment, the present invention provides a compositestructure for a bandage or wound dressing whereby a surface oncecontacting a patient may be subsequently contained in an integraldisposal bag, pouch or cavity. Accordingly, it should be understood thatnumerous alternatives are possible beyond the invertible structuresdescribed and illustrated herein. One further alternative is shown inFIG. 5, where the patient-contacting layer slides into a disposalsleeve. Other possibilities include the folding and/or rolling up of thepatient-contacting surface(s).

FIGS. 6A and 6B illustrate alternative embodiments of a wound dressingaccording to the invention, wherein one or more of the peripheral edgesof the dressing are prepared to permit a gathering thereof. Suchgathering may be convenient in the presence of a non-planar patientsurface, such as a shoulder or a knee, or in the event of a curved woundor incision, in which case the dressing may be articulated or bentwithin substantially the same plane. In addition, there may besituations in which both a curved patient surface and wound or incisionor present, which would also benefit from such gathering.

FIG. 6A shows one gathering according to the invention wherein the wounddressing 602 includes one or more accordion-like sections, wherein, forexample, at least a portion of at least one edge of the dressing iszig-zag-shaped, and which may, or may not, include an elastic memberrequiring stretching to ungather that section. Portion 606 has beenshown in broken-line form to indicate that these gathered portions maybe present on any or all of the edges of the dressing 602. In FIG. 6B,the means for gathering take the form of one or more V-shaped notches608 which, again, may be provided in various locations, as indicatedwith the broken-line areas 610.

FIGS. 7 and 8 illustrate ways in which invertible wound dressingsaccording to the invention may be fabricated. In particular, asillustrated obliquely in FIG. 7A one convenient approach is to adhere apiece of absorbent material 71 to an existing flattened bag 70 having anarea peripherally larger than the material 71 to avail an exposed,body-contacting adhesive. The flattened bag 70, which is preferablyconstructed of fluid-impermeable material, may be realized in a numberof ways, including partial folding and the use of peripheral adhesivesand/or thermal welding, as depicted in FIG. 8.

Turning first to FIG. 7B, there is shown in an exploded view, structuralcomponents conducive to the assembly of FIG. 7A. In particular, a firstpocket-forming sheet 72 is overlaid in co-extensive fashion with asecond such sheet 74, optionally including an inversion-assist membersuch as pull-tab 76 therebetween. As best understood with reference toFIG. 8, three edges of the 72-74 pocket are joined, as through thermalwelding, or the like, leaving an opening at one end, which would beleftward in FIG. 7B. The bottom or outwardly exposed surface of thesheet 74 receives an adhesive, to which a piece of absorbent material 77may be attached. Preferably, since the material 77 has a smaller areathan the 72-74 pocket, if adhesive is applied to the entire bottomsurface of the bag, a peripheral area of adhesive will be left exposedfor patient-contacting purposes, as discussed herein. In the event thatthe adhesive used for patient securement is insufficient to form a bondto the material 77, an additional adhesive 78 may be applied to thematerial 77, such that the marriage of the two adhesives results in asufficiently substantial bond therebetween. The same holds true with thestrip 73 of adhesive, which may be applied to the top side of the bag.Such an adhesive area 73 may not be that aggressive in terms of bondingpower until the structure is inverted, at which time the area 73 willnow be on the inside of the bag and in direct facing relation to aportion of the peripheral adhesive around the element 77, such that theuser may compress these two areas for a tight seal.

FIG. 8 illustrates a preferred way in which embodiments of the inventiondescribed above may be carried out as part of a continuous web process.Broadly, noting that portions of the apparatus area left out for thepurposes of clarity, an upper sheet 80 and a lower sheet 81 are fedbetween rollers into an area where a U-shaped bond 82 is formed asshown, optionally including inversion-assist means 83 which would havebeen dropped onto sheet 81 prior to the first set of rollers. Followingthis, an adhesive is applied through manifold 84, and a section ofabsorbent material 77 is dropped down from position 78 centrally ontothe adhesive. As discussed above, the material 77 may or may not includean additional adhesive to assist with bonding to the upperadhesive-containing web 80. At 85, the web is cut to provide a spacebetween wound dressings, and sterile layer/packaging sheets are appliedvia webs 86 and 87 through an additional set of rollers, after whichindividualized products may be severed and shipped to customers. Thoughnot shown in FIG. 7B, bag closure means discussed elsewhere, such asadhesive strip 73 would be applied in a manner apparent to one of skillin the art prior to the second set of rollers and sterile encapsulation.

I claim:
 1. A composite bandage for maintaining a fluid impermeablebarrier when applied to non-planar patient surfaces, including limbarticulations and curved incisions, comprising: an absorbent layerhaving a periphery and a non-stick surface for contacting a patient; afluid impermeable, flexible foam layer attached to the absorbent layer,the flexible foam layer including an adhesive and an edge that extendsaround the entire periphery of the absorbent layer by an amountsufficient to provide a fluid-impermeable barrier when secured to anon-planar or curved patient surface; and wherein one or more of theedges of the foam layer are gathered or notched.
 2. The bandage of claim1, wherein the bandage is rectangular.
 3. The bandage of claim 1,wherein the adhesive completely encircles the absorbent layer.
 4. Acomposite bandage for maintaining a fluid impermeable barrier whenapplied to non-planar patient surfaces, including limb articulations andcurved incisions, comprising: an absorbent layer having a periphery anda non-stick surface for contacting a patient; a fluid impermeable,flexible foam layer attached to the absorbent layer, the flexible foamlayer including an adhesive and an edge that extends around the entireperiphery of the absorbent layer by an amount sufficient to provide afluid-impermeable barrier when secured to a non-planar or curved patientsurface; and wherein the bandage also includes a pocket to permitinversion of the bandage after use.
 5. The bandage of claim 4, whereinthe bandage is rectangular.
 6. A composite bandage having a peripheraledge for maintaining a fluid impermeable barrier when applied tonon-planar patient surfaces, including limb articulations and curvedincisions, comprising: an absorbent layer having a non-stick layer forcontacting a patient; and a fluid impermeable layer, the smallestdimension of which is two inches or greater, the fluid impermeable layerincluding an adhesive and extending in all dimensions around theabsorbent layer by an amount sufficient to provide a fluid-impermeablebarrier when applied to a non-planar or curved patient surface.
 7. Thebandage of claim 6, wherein the fluid impermeable layer is comprised ofa flexible foam layer.
 8. A composite bandage having a peripheral edgefor maintaining a fluid impermeable barrier when applied to non-planarpatient surfaces, including limb articulations and curved incisions,comprising: an absorbent layer having a non-stick layer for contacting apatient; a fluid impermeable layer, the smallest dimension of which istwo inches or greater, the fluid impermeable layer including an adhesiveand extending in all dimensions around the absorbent layer by an amountsufficient to provide a fluid-impermeable barrier when applied to anon-planar or curved patient surface; wherein the peripheral edge of thebandage is gathered or notched to facilitate application of the bandageto non-planar patient surfaces including limb articulations, or curvedincisions while still maintaining a fluid impermeable barrier; andfurther including a pocket facilitating manual inversion of the bandageafter use.
 9. The bandage of claim 8, wherein the bandage isrectangular.
 10. The bandage of claim 8, wherein the fluid impermeablelayer is comprised of a flexible foam layer.